Social Support Counseling Intervention for Kidney Transplant Candidates (JtT)

December 13, 2024 updated by: Hennepin Healthcare Research Institute

Journey to Transplant: Virtual Coaching for Potential Kidney Transplant Patients and Their Social Support Networks

Virtual Coaching for Potential Kidney Transplant Patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Individuals who are eligible for kidney transplant will be recruited by phone or email and randomized into two groups, control and interventional counseling. The control group will be given a simple survey to fill and return while the interventional counseling will go through a group education and counseling session along with members of their social support networks. The interventional counseling will then complete a pre and post survey (same as control group). Survey answers will be recorded within REDCAP.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion

  • Determined by transplant center to be suitable for continuation in evaluation for listing (or a member of that person's social support network)
  • 18 Years of age or older
  • English-speaking
  • Willingness to participate with at least 2 social network members in the session and have calculator results shown to social network members (if a patient)
  • Able to provide informed consent

Exclusion

  • Prisoners
  • Individuals with impaired ability to consent
  • Pregnant females.
  • Patients who choose to opt out of research.
  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Pre-Transplant Counseling Intervention
Participants in control arm will undergo usual pre-transplant counseling as per the standard of care.
Experimental: Social Support Network Counseling Intervention
Participants in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks after their initial transplant evaluation and counseling.
Behavioral: Social Support Network Counseling Intervention
Social support counseling intervention for kidney transplant candidates along with their social support networks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct Answers on Knowledge of Kidney Transplant Options Assessment
Time Frame: one month
Questionnaire
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict Scores
Time Frame: one month
Questionnaire
one month
Social Support Scores
Time Frame: one month
Questionnaire
one month
Knowledge Scores
Time Frame: one month
Questionnaire
one month
Hearth Hope Index
Time Frame: one month
Questionnaire
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Collaborators

University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R01DK135730-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There might be an exchange of data with our collaborators with the study at the University of Minnesota-Twin Cities

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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